FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LERE NAIL & PLATE COMBIN. ONE PIECE FORGED
K Number: K851349
·
Decision May 29, 1985
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
4
Review Days
55
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Basic Information
- Device Name
- LERE NAIL & PLATE COMBIN. ONE PIECE FORGED
- K Number
- K851349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Medicalex
- Date Received
- April 4, 1985
- Decision Date
- May 29, 1985
- Product Code
- KTW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
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